NCT07537387

A Study on the Pursuit of Sustained Clearance of HBsAg in Chronic Hepatitis B(CHB) Patients With Previous Interferon Treatment Using Pegylated Interferon Alpha

A Prospective, Non-Randomized, Multicenter Study of Peginterferon Alfa for Pursuing Sustained Hepatitis B Surface Antigen(HBsAg) Clearance in Interferon-Pretreated Patients With Chronic Hepatitis B

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: xieqing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	PEG IFNα-2b monotherapy or combination therapy with NAs	Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
DRUG	NAs monotherapy group	Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.

Timeline

• Start date: 2026-04-30
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China